Rehabilitation Assessment and Progress Tracking System Based on Video Images for Dysphagic Patients

Healthy Clinical Trial

Official title:

Rehabilitation Assessment and Progress Tracking System Based on Video Images for Dysphagic Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05141539
• Other study ID #: COA. MURA2021/73
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: February 2023
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current cervical range of motion (CROM) and tongue movement measurement methods are not reliable between observers, which is not practical in real-world usage. This research is to develop the cervical range of motion measurement, and tongue movement estimation software, to compare between the developed software and the current measurement techniques, and to test in clinical aspects for reliability and validity assessment. The investigators investigate the developed software in healthy people in phase 1. In phases 2 and 3, the investigators compare the software to the standard measurement methods in dysphagic patients who have head and neck cancer for reliability and validity.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 88
• Est. completion date: September 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria in Phase 2

• Occupational therapist

1. This study requires the subject to be between 18 and 80 years old.

2. The subject needs to be Thai.

3. The subject can communicate in the Thai language.

4. Working as an occupational therapist in Ramathibodhi hospital.

5. The subject is consent.

• Head and neck cancer patients

1. This study requires the subject to be between 18 and 80 years old.

2. The subject needs to have stable vital signs.

3. The subject can make the body steady sit on the chair longer than 30 minutes.

4. The subject is diagnosed with head and neck cancer and treated at Ramathibodhi hospital.

5. Eating Assessment Tool (EAT-10) score is more than or equals 3.

6. Montreal Cognitive Assessment (MOCA) score is more than or equals 23.

7. The subject is consent. Exclusion Criteria in Phase 2

• Occupational therapist

1. Cannot participate in the experiment.

2. The therapist denied or withdrew.

• Head and neck cancer patients

1. Have pain around the examination area such as oral mucosa, tongue, and neck.

2. Participate in chemotherapy.

3. Cannot participant until the end of the experiment.

4. The subject denied or withdrew. Inclusion Criteria in Phase 3

• Dysphagic Specialist

1. The age is more than 18 years old.

2. The specialist is required to be Thai.

3. The specialist can communicate in the Thai language.

4. Working in oropharyngeal swallowing rehabilitation in the dysphagic unit at Ramathibodhi hospital for more than 3 years.

5. The specialist has papers related to swallowing rehabilitation.

6. The specialist is consent.

• Observers

1. This study requires the subject to be between 18 and 80 years old.

2. The observer can communicate in the Thai language.

3. The observer needs to be Thai.

4. Working in swallowing rehabilitation in Ramathibodhi hospital for more than a year.

5. The observer is consent.

• Head and neck cancer patients The criteria are the same as the inclusion criteria of head and neck cancer patients in phase 2. Exclusion Criteria in Phase 3
• Dysphagic Specialist

1. Cannot participant in the experiment.

2. The specialist denied or withdrew.

• Observers

1. Have a relationship with software development.

2. Cannot participate in the study until the end of the experiment.

3. The subject denied or withdrew.

• Head and neck cancer patients The criteria are the same as the exclusion criteria of head and neck cancer patients in phase 2.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Healthy

Intervention

Device:
• Rehabilitation assessment software
In phase 2, this software will be tested in occupational therapists, and head and neck cancer patients results for reliability and validity. In phase 3, the experiment in the oropharyngeal dysphagia specialists results in content validity, the comparison between the developed software, and VFSS and FOIS results in criterion-related validity, and the experiment in head and neck cancer patients results in reliability.
• VFSS and FOIS
In phase 3, this study applies VFSS and FOIS for the head and neck cancer patients for comparison with the developed rehabilitation assessment software for criterion-related validity.

Locations

Country	Name	City	State
Thailand	Department of Rehabilitation Medicine, Ramathibodhi Hospital	Phaya Thai	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra-rater reliability between the developed rehabilitation assessment software and the standard CROM measurement method.	The same investigator will repeat cervical range of motion measurement by using the developed rehabilitation software and the standard cervical range of motion (CROM) measurement method from the goniometer.	One hour
Primary	Inter-rater reliability between the developed rehabilitation assessment software and the standard CROM measurement method.	The cervical range of motion (CROM) measurement by using the developed rehabilitation software and the standard CROM measurement method from the goniometer will be repeated by different observers.	One hour
Primary	Concurrent measurement validity between the developed rehabilitation assessment software and the standard CROM measurement method.	The correlation of the concurrent cervical range of motion (CROM) measurement outcome at approximately the same time between the developed rehabilitation assessment software and the standard CROM measurement method from the goniometer.	One hour
Primary	Criterion-related validity between the developed rehabilitation assessment software, and VFSS and FOIS.	The criterion-related validity of the rehabilitation assessment software will be assessed by the correlation between the cervical range of motion measurement by the developed rehabilitation assessment software and the functional swallowing assessment by videofluoroscopic Swallowing Study (VFSS), and functional oral intake scale (FOIS).	One month